Expert Details

Expert in Pharmacokinetics/Pharmacodynamics

Expert ID: 735942 North Carolina, USA

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Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a compound’s development life cycle. Expert has worked for a variety of large and small pharmaceutical companies: he started in 1980 at Norwich Eaton Pharmaceuticals, which was acquired by Proctor & Gamble Pharmaceuticals. In 1997, he moved to Otsuka America Pharmaceuticals, and from there joined Human Genome Sciences in 2002. Human Genome Sciences was acquired by GlaxoSmithKline in 2012, and Expert then joined that company. After joining Parexel International in 2015, Expert formed his own consulting firm in 2016, and retired from that role in October 2019. Expert formed a second company in 2018 to pursue the development of nanobodies that neutralize bacterial toxins as therapeutic options for unmet medical needs; these activities are ongoing. During his career, Expert worked on drugs from a variety of therapeutic areas, including the anti-infective, anti-inflammatory, oncology, cardiovascular, renal, antiviral, immunomodulatory, and bioterrorism arenas. Beginning with his tenure at Human Genome Sciences, Expert’s work experiences have primarily centered on the development of monoclonal antibodies. He has supported numerous IND, BLA, and NDA filings and has contributed to ex-US regulatory filings.

Expert may consult nationally and internationally, and is also local to the following cities: Wake Forest, NC - Raleigh, NC - Durham, NC

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Education

Year Degree Subject Institution
Year: 1977 Degree: Medical Technologist (ASCP) Subject: Medical technology Institution: Cambridge City Hospital School of Medical Technology
Year: 1976 Degree: BS Subject: Biology Institution: State University College of New York at Geneseo

Work History

Years Employer Title Department Responsibilities
Years: 2018 to Present Employer: Undisclosed Title: Prinicipal Scientist Department: Responsibilities: Formed his own company in January 2018 to develop nanobodies that neutralize bacterial toxins as therapies to meet unmet medical needs. Three products currently in development.
Years: 2016 to 2019 Employer: Self Employed Title: Prinicipal Consultant Department: Responsibilities: Offered clients preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a compound’s development life cycle.
Years: 2015 to 2016 Employer: Parexel International Title: Director Scientific Affairs Department: Responsibilities: Responsible for the clinical pharmacokinetic and pharmacodynamic development strategies, modeling, and simulation, including the following:
1. Provide continued support to Sponsor projects.
2. Work with Sponsor teams to define clinical development strategies informed by pharmacokinetic/pharmacodynamics principles.
3. Prepare and implement pharmacokinetic and pharmacodynamic development plans for drug candidates.
4. Design the development plan studies and contribute to preparation of study protocols.
5. Coordinate with Sponsor and Parexel team members to support study conduct.
6. Develop of dosing recommendations for clinical studies.
7. Calculate of pharmacokinetic and pharmacodynamic parameters.
8. Interpret and present pharmacokinetic and pharmacodynamic data.
9. Prepare study reports and regulatory submission documents.
10. Interact with regulatory agencies to facilitate development and approval of drug candidates.
Years: 2012 to 2015 Employer: GlaxoSmithKline Title: Director Clinical Pharmacokinetics Department: Responsibilities: Contributed to the clinical pharmacokinetic and pharmacodynamic development of monoclonal antibody and small molecule drugs (anti-toxin, immunomodulatory, and oncology indications). Responsibilities similar to those described previously . Became a Parexel employee as the result of GlaxoSmithKline (GSK) restructuring that placed former GSK employees in a Parexel business unit intended to provide continuing support for GSK projects.
Years: 2002 to 2012 Employer: Human Genome Sciences, Inc. Title: Senior Pharmacokinetics Scientist II Department: Responsibilities: Responsible for the preclinical and clinical pharmacokinetic and pharmacodynamic development of several therapeutic protein drugs (anti-toxin, immunomodulatory, antiviral and oncology indications). Responsibilities similar to those described previously, with corresponding support for preclinical projects and supervision of some department members. Transferred to GlaxoSmithKline following its acquisition of Human Genome Sciences.
Years: 1997 to 2002 Employer: Otsuka America Pharmaceuticals Title: Senior Pharmacokineticist Department: Responsibilities: Responsible for the complete clinical pharmacokinetic and pharmacodynamic development of several drugs (CNS, anti-infective, cardiovascular, smooth muscle relaxant, and oncology indications), and supervisory responsibility for some department members.
Years: 1980 to 1997 Employer: Procter & Gamble Pharmaceuticals Title: Senior Scientist (Pharmacokineticist) Department: Responsibilities: Employed by Norwich Eaton Pharmaceuticals, Inc. and transferred to Procter & Gamble Pharmaceuticals in August 1993 following acquisition of Norwich Eaton by Procter & Gamble. In addition to gaining experience in the responsibilities described previously, experience was gained in the following during the development of several drugs (primarily anti-infective, cardiovascular, and muscle relaxant indications):
1. Development, validation, and application of bioanalytical methods, including liquid scintillation counting, column chromatography, spectrophotometry, fluorescence spectrophotometry, gas-liquid chromatography, and high performance liquid chromatography.
2. Conduct and monitoring of studies, including preparation of extemporaneous dosage forms, as well as the collection and processing of biological specimens.
Years: 1978 to 1980 Employer: Chenango Memorial Hospital (Norwich, NY) Title: Supervisor, Chemistry Department Department: Responsibilities: Responsibilities included routine analysis of patient specimens, supervision of day to day laboratory activities, use of quality control data to evaluate day to day laboratory performance, development of new procedures, evaluation of new instrumentation, and maintenance of instruments. Call hour duties required coverage for all laboratory departments.
Years: 1977 to 1978 Employer: Peter Bent Brigham Hospital (Boston, MA) Title: Medical Technologist, Chemistry Department Department: Responsibilities: Responsibilities included routine analysis of patient specimens, production of a serum pool for use as quality control material, ordering of supplies, and maintenance of instruments.

Career Accomplishments

Licenses / Certifications
1977, Medical Technologist (ASCP)
Professional Appointments
PROFESSIONAL MEETINGS
1. Eighth Wisconsin Update Conference: Scientific & Strategic Planning from NDA  IND,
University of Wisconsin, Madison, Wisconsin (1989).
2. American Association of Pharmaceutical Scientists Annual Meeting, Orlando, Florida (1993).
3. Fifth Symposium: Frontiers in Pharmacokinetics and Pharmacodynamics, Baltimore, Maryland
(1994).
4. American Association of Pharmaceutical Scientists Annual Meeting, San Diego, California
(1994).
5. American Association of Pharmaceutical Scientists Annual Meeting, Seattle, Washington
(1996).
6. American Society for Clinical Pharmacology and Therapeutics, Annual Meeting, San Diego,
California (1997).
7. American Society for Clinical Pharmacology and Therapeutics, Annual Meeting, New Orleans,
Louisiana (1998).
8. American Association of Pharmaceutical Scientists Annual Meeting, San Francisco, California
(1998)
9. Expanding the Role of Medical Imaging in Clinical Trials to Speed Drug Development
[organized by Barnett International Conference Group], Arlington, Virginia (1999).
10. Japan ’99: Overcoming the Current Challenges in the Registration of Products [organized by
Barnett International Conference Group], Arlington, Virginia (1999).
11. American Association of Pharmaceutical Scientists Annual Meeting, Indianapolis, Indiana
(2000).
12. First Annual Scientific Meeting. Pharmacogenetics Research Network and Knowledge Base,
Bethesda, Maryland (2001).
13. American Association of Pharmaceutical Scientists Annual Meeting, Denver, Colorado (2001).
14. Workshop on the Integration of Exposure Response Relationship in Drug Development and
Regulatory Assessment – Revisiting a Decade of Experience. Sponsored by the American
Association of Pharmaceutical Scientists and FDA, Arlington, VA (2002).
15. Clinical Trial Simulation in Drug Development Conference [organized by Institute for
International Research – USA], Washington, DC (2002).
16. Phases - Maximizing Clinical Efficiency Conference [organized by Institute for International
Research – USA], Washington, DC (2003).
17. ECPAG Conference and Themed Workshop: Validation Issues for Population PK/PD Models
and Software Systems, Rockville, MD (2004).
18. National Biotechnology Conference, American Association of Pharmaceutical Scientists, San
Francisco, California (2005).
19. ECPAG Conference and Themed Workshop: Technical Strategies and Best Practices for
Model-Based Decision-Making in Drug Development and Regulatory Review, Rockville, MD
(2006).
20. American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, Texas
(2006).
21. American Society for Microbiology Biodefense and Emerging Diseases Research Meeting,
Washington, DC (2007).
22. National Biotechnology Conference, American Association of Pharmaceutical Scientists, San
Diego, California (2007).
23. American Conference on Pharmacometrics, Inaugural Meeting, Tucson, Arizona (2008).
24. The International Liver Congress, European Association for the Study of the Liver, Vienna,
Austria (2010).
25. Digestive Disease Week, New Orleans, Louisiana (2010).
26. American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, Texas
(2013).
27. 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC
(2014).
28. 6th American Conference on Pharmacometrics, Arlington, Virginia (2015).
29. 7th American Conference on Pharmacometrics, Bellevue, Washington (2016).
30. American Society for Microbiology Biothreats Meeting, Arlington, Virginia (2019).
Publications and Patents Summary
Presentations: 5
Posters: 37
Publications: 20

Additional Experience

Training / Seminars
Biopharmaceutics and Bioavailability Short Course, University of Wisconsin, Madison, Wisconsin (1983).
2. Workshop in Pharmacokinetic Modeling (sponsored by Statistical Consultants, Inc.), Lexington, Kentucky (1984).
3. Clinical Trials: Pharmacokinetics and Pharmacodynamics Variability in Drug Response, Center for Professional Development, East Brunswick, New Jersey (1987).
4. The Seventh One-Week Workshop on Advanced Methods in Pharmacokinetics and Pharmacodynamics, University of California, San Francisco, California (1990).
5. A Short Course in Population Pharmacokinetic Data Analysis Using the NONMEM System (sponsored by the University of California, Georgetown University, and the American Society for Clinical Pharmacology and Therapeutics), Rockville, Maryland (1992).
6. American Association of Pharmaceutical Scientists Short Course: Pharmacokinetic and Pharmacodynamic Modeling, Orlando, Florida (1993).
7. Pharmaceutical Applications of Neural Computing Technology, Course No. 25 840 745 001, College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (Winter Quarter 1994).
8. American Association of Pharmaceutical Scientists Short Course: Recent Advances in the In Vivo Evaluation of Dosage Forms and Drug Absorption Phenomena, San Diego, California (1994).
9. Symposium on Population PK/PD Modeling, Individualized Drug Therapy, and New 'Multiple Model' Design of Drug Dosage (sponsored by the University of Southern California, ACCP-AMIA-IMIA), Washington DC (1995).
10. SAS Programming, a SAS Institute course, Cincinnati, Ohio (1996).
11. American Association of Pharmaceutical Scientists Short Course: Introduction to Cytochrome P450: Everything You Always Wanted to Know But Were Afraid to Ask, Seattle, Washington (1996).
12. American Association of Pharmaceutical Scientists Short Course: Interspecies Scaling: Techniques, Concepts and Considerations, San Francisco, California (1998).
13. Population Pharmacokinetics Workshop (NONMEM Analysis) [sponsored by GloboMax LLC], Hanover, MD (1999).
14. American Association of Pharmaceutical Scientists Short Course: Predicting Human Pharmacokinetics, Indianapolis, Indiana (2000).
15. American Association of Pharmaceutical Scientists Short Course: Clinical Trial Simulations, Denver, Colorado (2001).
16. American Association of Pharmaceutical Scientists Short Course: PK/PD Science in Drug Development Plans: When, What and How?, San Antonio, Texas (2006).
17. American Association of Pharmaceutical Scientists Short Course: Critical Path Initiative Role of PK/PD for Biotechnology Products, San Diego, California (2007).
18. American Association of Pharmaceutical Scientists Short Course: Preclinical Strategies for the Development of Biotherapeutic Modalities: Discovery to FIH, San Francisco, California (2011).
19. Population Modeling Methodology using Phoenix NLME [Pharsight course at Human Genome Sciences], Rockville, MD (2011).
20. American Association of Pharmaceutical Scientists Short Course: Translational Challenges in Developing Antibody-Drug Conjugates, San Diego, California (2012).

Fields of Expertise

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